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Company

Original Job Post

Resonetics · 3 days ago

Quality Engineer

San Diego, CA

Full-time

Onsite

Senior Level

$80K/yr - $90K/yr

10+ years exp

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Life ScienceManufacturing

H1B Sponsorship

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Responsibilities

Work with and lead cross functional teams utilizing the Product Development Process to ensure robust systems and controls are in place to produce defect free product while meeting business objectives and customer expectations.

Influence change and ensure understanding and compliance to 21CFR820, ISO 13485 and the Product Development process Drive and participate in Continuous improvement and Process validation activities using DOE's, FMEA's, Quality Plans, Gage R&R and other Quality tools

Work through unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on facts

Review and approve protocols, validation documents, investigations and procedure

Provides support by conducting investigations and assisting in data and information collection as required for quality events Interfaces as a subject matter expert with the FDA and other government agencies during site inspections.

Responsible for the development of process and quality procedures.

Implement Continuous improvement methodology and metrics in cell(s) to improve business metrics

Customer liaison for all quality related issues.

Mentor and train other engineers/technicians in quality methodologies and regulatory requirements.

Proactively develop improvement ideas based on experienced assessment of departmental and company performance Represent Quality in project team meetings and on assigned projects

Qualification

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Quality engineeringTechnical writingStatistical softwareMinitabCommunication

Required

Minimum 10 years experience in a Quality Engineering role for a medical device manufacturer and/or start-up company

Demonstrated technical writing and communication skills

Working knowledge of Statistical software and/or Minitab

Bachelor's degree or equivalent experience

Company

Resonetics

Resonetics provides laser micromachining contract manufacturing solutions and systems for the life sciences and other high precision.

Founded in 1987

Nashua, New Hampshire, USA

1,001-5,000 employees

http://www.resonetics.com

H1B Sponsorship

Resonetics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2022 (1)

2021 (3)

2020 (1)